Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273

NCT06164431 | Completed Phase 1

• 1 other identifier: ZSP1273-22-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions. Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

  Day 1 to Day 20

• Area under the concentration-time curve from time zero to infinity (AUCinf)

  The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

  Day 1 to Day 20

• Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)

  The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.

  Day 1 to Day 20

Secondary Outcomes (1)

• Number of participants with drug-related adverse events as assessed by CTCAE v5.0

  Day 1 to Day 20

Study Arms (2)

ZSP1273 Sequence 1

EXPERIMENTAL

Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period.

Drug: ZSP1273 tablet; Drug: zsp1273 granules

ZSP1273 Sequence 2

EXPERIMENTAL

Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period.

Drug: ZSP1273 tablet; Drug: zsp1273 granules

Interventions

ZSP1273 tablet DRUG

Participants receive ZSP1273 tablet orally.

ZSP1273 Sequence 1; ZSP1273 Sequence 2

zsp1273 granules DRUG

Participants receive ZSP1273 granules orally.

ZSP1273 Sequence 1; ZSP1273 Sequence 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight \>50 kg at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
• Ability to understand and willingness to sign a written informed consent form;
• Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.

You may not qualify if:

• Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
• Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
• Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
• Participants who donated blood/bleeding profusely (\> 400 mL) 3 months prior to randomization;
• Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF \> 450ms;
• Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
• Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of dysphagia or any gastrointestinal disorder that affect absorption

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Guangdong Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

ZSP1273

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 11, 2023
• Study Start: November 23, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 22, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

CN (1)